The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0842-2021·Announced 2021-01-20

Ansh Labs Recalls SARS-CoV-2 IgM ELISA Kits for Labeling Update

Ansh Labs is recalling 327 SARS-CoV-2 IgM ELISA kits to update instructions and reduce the risk of false test results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling update to reduce the risk of false test results, which aligns with the rubric for moderate severity involving minor labeling errors or precautionary measures.

Plain-English summary

Ansh Labs, LLC is recalling 327 kits of the AnshLabs SARS-CoV-2 IgM ELISA (u-Capture) In Vitro Diagnostic (IVD) product. The recall involves specific lots with expiration dates ranging from October 2021 to October 2021. The affected kits were distributed nationwide in the United States, including in Texas, Missouri, Oklahoma, Maryland, Florida, New York, Oregon, Georgia, and North Carolina.

The recall is a labeling update intended to reduce the risk of false positive or false negative results. The instructions for use (IFU) are being updated to remove Plasma as a listed sample type and to include information about potential cross-reactivity with non-SARS-CoV-2 strains in the limitations section. The product is intended for the qualitative detection of IgM antibodies in serum collected from individuals suspected of having COVID-19 infection.

Healthcare providers and laboratories should stop using the affected kits and contact Ansh Labs for further instructions regarding the return or disposal of the product.

The recalled product

Product
AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CONC 1 x 1.5 mL, Calibrators A-C 3 x 1.2 mL, CONJ DIL 1 X 12 mL, Stop SOLN 1 X 12 mL, TMB SOLN 1 X 12 mL, WASH CONC A 1 X 60 mL…
Manufacturer
Ansh Labs, LLC
Category
Medical Device — In Vitro Diagnostics
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Lot #/Expiration Date: 040720/2021-10-06
  • 041620/2021-10-15
  • 041720/2021-10-18
  • 042420/2021-10-15
  • 042720-A/2021-10-26

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

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